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[Federal Register Volume 89, Number 247 (Thursday, December 26, 2024)]
[Notices]
[Pages 105041-105043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30637]

[[Page 105041]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2024-0454; FRL 12023-01-OW]

Draft National Recommended Ambient Water Quality Criteria for the 
Protection of Human Health for Perfluorooctanoic Acid, Perfluorooctane 
Sulfonic Acid, and Perfluorobutane Sulfonic Acid

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of draft Clean Water Act (CWA) national recommended 
ambient water quality criteria (AWQC) for the protection of human 
health for three per- and polyfluoroalkyl substances (PFAS)--
perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), 
and perfluorobutane sulfonic acid (PFBS)--for a 60-day public comment 
period. The EPA has developed these draft PFAS national recommended 
human health criteria (HHC) to reflect the latest scientific 
information, consistent with current EPA guidance, methods, and 
longstanding practice. When PFAS national recommended HHC are 
finalized, they will provide information that States and Tribes may 
consider when adopting water quality standards.

DATES: Comments must be received on or before February 24, 2025.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OW-2024-0454, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/ 
(our preferred method). Follow the online instructions for submitting 
comments.
     Email: [email protected]. Include Docket ID No. EPA-HQ-OW-
2024-0454 in the subject line of the message.
     Mail: U.S. Environmental Protection Agency, EPA Docket 
Center, Water Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW, 
Washington, DC 20460.
     Hand Delivery or Courier: EPA Docket Center, WJC West 
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. 
The Docket Center's hours of operations are 8:30 a.m. to 4:30 p.m., 
Monday through Friday (except Federal holidays).
    Instructions: All submissions received must include the Docket ID 
No. for this document. Comments received may be posted without change 
to https://www.regulations.gov/, including any personal information 
provided. For detailed instructions on sending comments and additional 
information, see the ``Public Participation'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Brandi Echols, Office of Water, Health 
and Ecological Criteria Division (4304T), Environmental Protection 
Agency, 1301 Constitution Ave. NW, Washington, DC 20460; telephone 
number: (202) 566-2717; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. How can I get copies of these documents and other related 
information?

    The EPA has established Docket ID No. EPA-HQ-OW-2024-0454 for three 
draft PFAS human health criteria: ``Draft Human Health Ambient Water 
Quality Criteria: Perfluorooctanoic Acid (PFOA) and Related Salts;'' 
``Draft Human Health Ambient Water Quality Criteria: Perfluorooctane 
Sulfonic Acid (PFOS) and Related Salts;'' and ``Draft Human Health 
Ambient Water Quality Criteria: Perfluorobutane Sulfonic Acid (PFBS) 
and Related Salts.'' Publicly available docket materials are available 
either electronically through https://www.regulations.gov or in hard 
copy at the EPA Docket Center, WJC West Building, Room 3334, 1301 
Constitution Ave. NW, Washington, DC 20004. The Docket Center's hours 
of operations are 8:30 a.m. to 4:30 p.m., Monday through Friday (except 
Federal holidays). For further information on the EPA Docket Center 
services and the current status, see: https://www.epa.gov/dockets.
    The three draft human health criteria documents can be accessed on 
the EPA's website through the following link: https://www.epa.gov/wqc/human-health-water-quality-criteria-pfas

B. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2024-
0454, at https://www.regulations.gov (our preferred method) or the 
other methods identified in the ADDRESSES section. Once submitted, 
comments cannot be edited or removed from the docket. The EPA may 
publish any comment received to its public docket. Do not submit to the 
EPA's docket at https://www.regulations.gov any information you 
consider to be Confidential Business Information (CBI), Proprietary 
Business Information (PBI), or other information whose disclosure is 
restricted by statute. Multimedia submissions (audio, video, etc.) must 
be accompanied by a written comment. The written comment is considered 
the official comment and should include discussion of all points you 
wish to make. The EPA will generally not consider comments or comment 
contents located outside of the primary submission (i.e., on the web, 
cloud, or other file sharing system). Please visit https://www.epa.gov/dockets/commenting-epa-dockets for additional submission methods; the 
full EPA public comment policy; information about CBI, PBI, or 
multimedia submissions; and general guidance on making effective 
comments.

C. What should I consider as I prepare my comments for the EPA?

    In preparation for submitting comments to the EPA on this action, 
please review the draft chemical-specific criteria documents the EPA is 
publishing in the public docket for this action under Docket ID No. 
EPA-HQ-OW-2024-0454. Provide the EPA with comments regarding scientific 
views related to the draft national recommended water quality criteria 
for protecting human health. Include any recommended references for 
data and other scientific information to be considered by the EPA. To 
ensure that the EPA can properly respond to comments, commenters should 
cite the section(s) or chemical(s) in the draft criteria documents to 
which each comment refers. Commenters should use a separate paragraph 
for each issue discussed and submit any references cited in their 
comments. If you submit an electronic comment, the EPA recommends that 
you include your name and other contact information in the body of your 
comment. Electronic files should avoid any form of encryption and 
should be free of any defects or viruses.

II. Background

A. What are PFAS and what are PFOA, PFOS, and PFBS?

    Per- and polyfluoroalkyl substances (PFAS) are a large class of 
thousands of synthetic chemicals that have been in use in the United 
States and around the world since the 1940s. The ability for PFAS to 
withstand heat and repel water and stains makes them useful in a wide 
variety of consumer, commercial, and industrial products, and in the 
manufacturing of other products and chemicals. Current scientific 
research and available evidence have shown the potential for harmful 
human health effects after being exposed to some PFAS, even at very low 
levels. PFAS' persistence and resistance to hydrolysis,

[[Page 105042]]

photolysis, metabolism, and microbial degradation raise additional 
concerns about human exposure and health effects.
    The EPA has developed draft recommended criteria for three PFAS: 
perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), 
and perfluorobutane sulfonic acid (PFBS). In the United States, most 
production of PFOA and PFOS, along with other long-chain PFAS, has been 
phased out and generally replaced by production of other PFAS. PFOA and 
its precursors have been used in flame repellents, cosmetics, paints, 
polishes, and processing aids used in the manufacture of nonstick 
coatings on cookware. PFOS has been used in a variety of products 
including surface treatments for soil and stain resistance, coating of 
paper, and in specialized applications such as firefighting foams. PFBS 
has been used as a replacement chemical for PFOS. Prior to its use as a 
PFOS replacement, PFBS had been produced as a byproduct and was present 
in consumer products as an impurity. Environmental releases of PFBS may 
result directly from the production and use of PFBS itself, production 
and use of PFBS-related substances for various applications, and/or 
from the degradation of PFBS precursors (i.e., substances that may form 
PFBS during use, as a waste, or in the environment). Adverse human 
health effects associated with exposure to PFOA or PFOS include but are 
not limited to effects on the liver, growth and development (e.g., low 
birth weight), the immune system (e.g., reduced response to vaccines), 
lipid levels (e.g., high cholesterol), as well as increased risk of 
certain types of cancer. Adverse human health effects associated with 
exposure to PFBS include but are not limited to thyroid, developmental, 
and kidney effects.

B. What are the EPA's national recommended ambient water quality 
criteria for the protection of human health?

    Section 304(a)(1) of the CWA requires the EPA to develop, publish, 
and, from time to time, revise criteria for protection of water quality 
and human health that accurately reflect the latest scientific 
knowledge. HHC developed under CWA section 304(a) are based solely on 
data and scientific judgments on the relationship between pollutant 
concentrations and human health effects. CWA section 304(a) criteria do 
not reflect consideration of economic impacts or the technological 
feasibility of meeting pollutant concentrations in ambient water. HHC 
are scientifically derived numeric concentrations of a pollutant that 
are expected to protect human health from the adverse effects of that 
pollutant in ambient water. HHC are designed to minimize the risk of 
adverse effects occurring to humans from chronic (lifetime) exposure to 
substances through drinking water and eating fish and shellfish from 
inland and nearshore waters.
    Under the CWA and its implementing regulations, States and 
authorized Tribes are required to adopt water quality criteria to 
protect designated uses (e.g., public water supply, recreational use, 
or industrial use). The recommended HHC provide scientific information 
to States and authorized Tribes when they establish water quality 
standards that ultimately provide a basis for assessing water body 
health and controlling discharges of pollutants. For each contaminant, 
the EPA derives two recommended HHC: one criterion is based on the 
consumption of both water and freshwater/estuarine fish and shellfish 
(collectively referred to as ``organisms''), and the other is based on 
the consumption of organisms alone. The applicability of one criterion 
over the other depends on the designated use of a particular water body 
or water bodies (e.g., public water supply vs. fishable waters). The 
EPA recommends applying the organism-only HHC to a water body where the 
designated use includes supporting fishable uses under section 101(a) 
of the CWA but not a drinking water supply source (e.g., non-potable 
estuarine waters that support fish or shellfish for human consumption).
    The EPA's national recommended water quality criteria are not 
regulations, and they do not substitute for the CWA or regulations. The 
EPA's recommended criteria do not impose legally binding requirements. 
States and authorized Tribes have the discretion to adopt, where 
appropriate, other scientifically defensible water quality criteria 
that differ from the EPA's CWA section 304(a) national recommendations.

III. Overview of EPA's Draft Human Health Criteria for PFOA, PFOS, and 
PFBS

    The EPA is publishing draft national recommended HHC for PFOA, 
PFOS, and PFBS, based on the latest scientific knowledge and following 
the EPA's longstanding, peer reviewed methodology for deriving human 
health criteria. See Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health (2000), EPA-822-B-00-004, 
October 2000. HHC are developed using a mathematical equation that 
includes information on human health toxicity (non-cancer and cancer 
effects), exposure factors (specifically, fish consumption rates, body 
weight and drinking water intake), bioaccumulation potential, and 
consideration of potentially significant exposure sources beyond 
drinking water and freshwater/estuarine fish and shellfish consumption 
(e.g., other foods, dust, consumer products; termed ``relative source 
contribution'').
    The EPA derived the draft HHC using the latest scientific 
information regarding human health toxicity and potential exposures via 
drinking water and eating fish and shellfish from inland and nearshore 
waters. Specifically, the EPA derived the draft HHC using final EPA 
toxicity values (reference doses, cancer slope factors) for each of the 
three PFAS, which have undergone external peer review and public 
comment. To account for human exposure to these three individual PFAS 
from the fish and shellfish consumption pathway, the EPA developed 
draft bioaccumulation factors for freshwater and estuarine fish and 
shellfish, according to longstanding Agency methods. Consistent with 
past practice, the EPA derived the draft HHC using 90th percentile per 
capita rates for fish and shellfish consumption and drinking water 
ingestion, and a mean body weight for adults, all based on national 
survey data. The EPA derived a relative source contribution for each 
PFAS to ensure that a person's total exposure to each chemical does not 
exceed its noncancer toxicity value (reference dose).
    The draft national recommended HHC for the three PFAS are 
summarized in table 1. Each of the draft criteria documents 
transparently describes the human health toxicity and exposure 
information that the EPA used to derive the HHC. Each draft criteria 
document also provides an illustrative example to assist States and 
Tribes in the consideration of water quality standards for PFAS 
mixtures.

   Table 1--Draft Human Health Criteria (HHC) for PFOA, PFOS, and PFBS
------------------------------------------------------------------------
                                                     Water +
                                                     Organism   Organism
                       PFAS                          HHC (ng/   Only HHC
                                                        L)       (ng/L)
------------------------------------------------------------------------
PFOA..............................................     0.0009    0.00036
PFOS..............................................       0.06       0.07
PFBS..............................................        400        500
------------------------------------------------------------------------

[[Page 105043]]

IV. The EPA's Request for Comments and Next Steps

    The EPA will consider the comments received, revise the criteria 
documents, and prepare final national recommended HHC for PFOA, PFOS, 
and PFBS that reflect EPA's consideration of those comments. The EPA 
will announce the availability of the final national recommended HHC 
for these three PFAS in the Federal Register. When final, these HHC 
will provide information that States and Tribes may consider when 
adopting water quality standards for PFOA, PFOS, and PFBS. The EPA 
expects to develop additional HHC for PFAS as scientific information 
becomes available.

Bruno Pigott,
Principal Deputy Assistant Administrator.
[FR Doc. 2024-30637 Filed 12-23-24; 8:45 am]
BILLING CODE 6560-50-P
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